PPOS与GnRHa长方案在首次体外受精/卵胞浆内单精子注射周期临床结局中的比较：一项随机临床试验
Comparison Between PPOS and GnRHa-Long Protocol in Clinical Outcome with the First IVF/ICSI Cycle: A Randomized Clinical Trial.
作者信息
Xi Qianwen, Tao Yu, Qiu Meiting, Wang Yun, Kuang Yanping
机构信息
Department of Assisted Reproduction, Shanghai Ninth People's Hospital Affiliated to JiaoTong University School of Medicine, Shanghai, People's Republic of China.
出版信息
Clin Epidemiol. 2020 Mar 3;12:261-272. doi: 10.2147/CLEP.S226414. eCollection 2020.
PURPOSE
To investigate whether progestin-primed ovarian stimulation (PPOS) can be an alternative as gonadotrophin-releasing hormone agonist (GnRHa) long protocol for infertile women with normal ovarian reserve during IVF/ICSI.
METHODS
A prospective randomized controlled trial (RCT) including 257 patients was conducted between 1 August 2017 to 1 January 2018. Computerized randomization was performed to assign participants into two treatment groups at a 1:1 ratio: PPOS (130 patients) or GnRHa long protocol (127 patients) followed by their first IVF/ICSI with fresh/frozen embryo transfer. The primary outcome was the number of oocytes retrieved. Patients with normal ovarian reserve undergoing their first IVF/ICSI procedure were included. The embryological and clinical outcomes were measured. Only the first embryo transfer cycle was followed-up.
RESULTS
Basic characteristics such as infertility duration, age, and body mass index (BMI) were comparable in both groups. No significant difference was found in the number (mean ± SD) oocytes retrieved [11.8 ± 6.5 for PPOS vs 11.3 ± 5.6 for GnRHa long protocol] or viable embryos [4.5 ± 3.0 for PPOS vs 4.2 ± 2.9 for GnRHa long protocol] between the groups. No patient from either group experienced a premature LH surge during the whole process of ovarian stimulation. Besides, there was no moderate or severe ovarian hyperstimulation syndrome during the ovarian stimulation in PPOS group while three patients suffered it in the GnRHa long protocol group. There was no significant difference in the clinical pregnancy rate of the first embryos transfer cycle between the two groups.
CONCLUSION
PPOS in combination with embryo cryopreservation as an ovarian stimulation regimen was as effective as GnRHa long protocol during controlled ovarian stimulation (COH) under different endocrinal mechanisms. It can also achieve comparable embryological and clinical outcomes while reducing the incidence of moderate and severe ovarian hyperstimulation syndrome (OHSS) and HMG dosage. It can be an alternative of the treatments for infertile patients with normal ovarian reserve undergoing IVF as well as traditional protocols.
TRIAL REGISTRATION NUMBER
ChiCTR-INR-17012089.
TRIAL REGISTRATION DATE
Chictr.org.cn: 23 July 2017.
DATE OF FIRST PATIENT’S ENROLLMENT: 1 August 2017.
目的
探讨在体外受精/卵胞浆内单精子注射（IVF/ICSI）过程中，孕激素预刺激卵巢方案（PPOS）能否作为促性腺激素释放激素激动剂（GnRHa）长方案的替代方案，用于卵巢储备功能正常的不孕女性。
方法
于2017年8月1日至2018年1月1日进行了一项前瞻性随机对照试验（RCT），纳入257例患者。通过计算机随机化以1:1的比例将参与者分为两个治疗组：PPOS组（130例患者）或GnRHa长方案组（127例患者），随后进行首次IVF/ICSI及新鲜/冷冻胚胎移植。主要结局指标为获卵数。纳入首次接受IVF/ICSI治疗且卵巢储备功能正常的患者。测量胚胎学和临床结局。仅对第一个胚胎移植周期进行随访。
结果
两组患者的不孕年限、年龄和体重指数（BMI）等基本特征具有可比性。两组间获卵数（平均值±标准差）[PPOS组为11.8±6.5，GnRHa长方案组为11.3±5.6]或可移植胚胎数[PPOS组为4.5±3.0，GnRHa长方案组为4.2±2.9]均无显著差异。两组患者在整个卵巢刺激过程中均未出现过早促黄体生成素（LH）峰。此外，PPOS组在卵巢刺激过程中未发生中度或重度卵巢过度刺激综合征（OHSS），而GnRHa长方案组有3例患者发生。两组第一个胚胎移植周期的临床妊娠率无显著差异。
结论
PPOS联合胚胎冷冻保存作为一种卵巢刺激方案，在不同内分泌机制下的控制性卵巢刺激（COH）过程中与GnRHa长方案同样有效。它还能在降低中度和重度卵巢过度刺激综合征（OHSS）发生率及减少人绝经期促性腺激素（HMG）用量的同时，取得相当的胚胎学和临床结局。它可作为卵巢储备功能正常的不孕患者进行IVF治疗的替代方案以及传统方案。
试验注册号
ChiCTR-INR-17012089。
试验注册日期
Chictr.org.cn：2017年7月23日。
首例患者入组日期
The Date of First Patient’s Enrollment：2017年8月1日。
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